{ "FullStudy":{ "Rank":217797, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516710", "OrgStudyIdInfo":{ "OrgStudyId":"2011/1285/REK sør-øst B" }, "Organization":{ "OrgFullName":"Oslo University Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study", "OfficialTitle":"Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases", "Acronym":"Oslo-CoMet" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2025", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 4, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 6, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Åsmund Avdem Fretland", "ResponsiblePartyInvestigatorTitle":"MD", "ResponsiblePartyInvestigatorAffiliation":"Oslo University Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Oslo University Hospital", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Helse Sor-Ost", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.\n\nThe primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.", "DetailedDescription":"Full protocol is published open access in Trialsjournal:\n\nhttp://www.trialsjournal.com/content/16/1/73" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Secondary Malignant Neoplasm of Liver", "Colorectal Neoplasms" ] }, "KeywordList":{ "Keyword":[ "Open liver resection", "Laparoscopic liver resection", "Colorectal cancer liver metastases" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"280", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Open liver resection", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients will be operated with open liver resection", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Open liver resection" ] } },{ "ArmGroupLabel":"Laparoscopic liver resection", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Patients will be operated with laparoscopic liver resection", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Laparoscopic liver resection" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Open liver resection", "InterventionDescription":"Patients will be operated with open liver resection for colorectal metastasis", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Open liver resection" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Open liver resection using standard technique:", "Ligasure", "CUSA", "Thunderbeat", "Autosonix", "SonoSurg", "Ultrasound" ] } },{ "InterventionType":"Procedure", "InterventionName":"Laparoscopic liver resection", "InterventionDescription":"Patients will be operated with laparoscopic liver resection", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Laparoscopic liver resection" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Laparoscopic liver resection using standardized technique:", "Ligasure", "CUSA", "Thunderbeat", "Autosonix", "SonoSurg", "Laparoscopic ultrasound" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Perioperative morbidity", "PrimaryOutcomeDescription":"This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index", "PrimaryOutcomeTimeFrame":"Within 30 days after surgery" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"5 year survival", "SecondaryOutcomeDescription":"5 year survival\n\noverall\ndisease free\nrecurrence free", "SecondaryOutcomeTimeFrame":"5 years after surgery" },{ "SecondaryOutcomeMeasure":"Recurrence pattern", "SecondaryOutcomeDescription":"Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded.", "SecondaryOutcomeTimeFrame":"5 years" },{ "SecondaryOutcomeMeasure":"Immediate oncologic outcome", "SecondaryOutcomeDescription":"Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.", "SecondaryOutcomeTimeFrame":"2 months after surgery" },{ "SecondaryOutcomeMeasure":"Postoperative quality of life", "SecondaryOutcomeDescription":"Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms", "SecondaryOutcomeTimeFrame":"Up to 2 years" },{ "SecondaryOutcomeMeasure":"Surgical trauma and activation of the immune system", "SecondaryOutcomeDescription":"Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.", "SecondaryOutcomeTimeFrame":"72 hours" },{ "SecondaryOutcomeMeasure":"Health economy", "SecondaryOutcomeDescription":"We intend to compare overall cost of treatment for the hospital and for the health care system", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Severity of postoperative pain", "SecondaryOutcomeDescription":"To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA.", "SecondaryOutcomeTimeFrame":"4 months" },{ "SecondaryOutcomeMeasure":"Molecular biology", "SecondaryOutcomeDescription":"The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.", "SecondaryOutcomeTimeFrame":"20 years" },{ "SecondaryOutcomeMeasure":"Anti-tumor immunology", "SecondaryOutcomeDescription":"The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors", "SecondaryOutcomeTimeFrame":"20 years" },{ "SecondaryOutcomeMeasure":"Imaging", "SecondaryOutcomeDescription":"The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases.", "SecondaryOutcomeTimeFrame":"5 years" },{ "SecondaryOutcomeMeasure":"Severity of morbidity", "SecondaryOutcomeDescription":"Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system", "SecondaryOutcomeTimeFrame":"30 days" },{ "SecondaryOutcomeMeasure":"Level of adhesions", "SecondaryOutcomeDescription":"Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring.", "SecondaryOutcomeTimeFrame":"2 years" },{ "SecondaryOutcomeMeasure":"Number of patients that complete adjuvant oncologic treatment", "SecondaryOutcomeDescription":"Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Readmissions", "SecondaryOutcomeDescription":"Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.", "SecondaryOutcomeTimeFrame":"30 days" },{ "SecondaryOutcomeMeasure":"Incidence of incisional hernia", "SecondaryOutcomeDescription":"CT scans will be performed to examine for incisional hernia 1 year after surgery", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation\n\nExclusion Criteria:\n\nInability to give written informed concent\nPatients with tumors that can't be resected without reconstruction of vessels or bile ducts\nPatients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation\nPatients with extrahepatic metastasis except resectable metastasis in lungs and adrenals\nPre- and peroperative diagnosis of non radically treatable disease", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bjørn Edwin, MD, PhD", "OverallOfficialAffiliation":"Oslo University Hospital - The Interventional Centre", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Bjorn Edwin, MD, PhD", "OverallOfficialAffiliation":"Oslo University Hospital - The Interventional Centre", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital", "LocationCity":"Oslo", "LocationZip":"0424", "LocationCountry":"Norway" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"31322735", "ReferenceType":"derived", "ReferenceCitation":"Fretland ÅA, Dagenborg VJ, Waaler Bjørnelv GM, Aghayan DL, Kazaryan AM, Barkhatov L, Kristiansen R, Fagerland MW, Edwin B, Andersen MH. Quality of life from a randomized trial of laparoscopic or open liver resection for colorectal liver metastases. Br J Surg. 2019 Sep;106(10):1372-1380. doi: 10.1002/bjs.11227. Epub 2019 Jul 19." },{ "ReferencePMID":"25872027", "ReferenceType":"derived", "ReferenceCitation":"Fretland ÅA, Kazaryan AM, Bjørnbeth BA, Flatmark K, Andersen MH, Tønnessen TI, Bjørnelv GM, Fagerland MW, Kristiansen R, Øyri K, Edwin B. Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial. Trials. 2015 Mar 4;16:73. doi: 10.1186/s13063-015-0577-5." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"Not decided yet but results will be public no matter the outcome of the trial" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008110", "InterventionMeshTerm":"Liver Extracts" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000006397", "InterventionAncestorTerm":"Hematinics" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M9693", "InterventionBrowseLeafName":"Liver Extracts", "InterventionBrowseLeafAsFound":"Liver", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8068", "InterventionBrowseLeafName":"Hematinics", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009362", "ConditionMeshTerm":"Neoplasm Metastasis" },{ "ConditionMeshId":"D000015179", "ConditionMeshTerm":"Colorectal Neoplasms" },{ "ConditionMeshId":"D000008113", "ConditionMeshTerm":"Liver Neoplasms" },{ "ConditionMeshId":"D000009369", "ConditionMeshTerm":"Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009385", "ConditionAncestorTerm":"Neoplastic Processes" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000007414", "ConditionAncestorTerm":"Intestinal Neoplasms" },{ "ConditionAncestorId":"D000005770", "ConditionAncestorTerm":"Gastrointestinal Neoplasms" },{ "ConditionAncestorId":"D000004067", "ConditionAncestorTerm":"Digestive System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000003108", "ConditionAncestorTerm":"Colonic Diseases" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" },{ "ConditionAncestorId":"D000012002", "ConditionAncestorTerm":"Rectal Diseases" },{ "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16473", "ConditionBrowseLeafName":"Colorectal Neoplasms", "ConditionBrowseLeafAsFound":"Colorectal Neoplasms", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafAsFound":"Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9696", "ConditionBrowseLeafName":"Liver Neoplasms", "ConditionBrowseLeafAsFound":"Malignant Neoplasm of Liver", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10913", "ConditionBrowseLeafName":"Neoplastic Processes", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9031", "ConditionBrowseLeafName":"Intestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7469", "ConditionBrowseLeafName":"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5839", "ConditionBrowseLeafName":"Digestive System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4919", "ConditionBrowseLeafName":"Colonic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13427", "ConditionBrowseLeafName":"Rectal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }